
Approximately three months have elapsed since the initial notification to patients and healthcare providers regarding Nurse Assist’s voluntary recall of various sodium chloride irrigation and sterile water products. The FDA is now emphasizing the extensive reach of the recall and the potential risks it poses to consumers.
Initiating a voluntary recall on November 6, Nurse Assist took action after finding certain products lacked sterility. Although no adverse events were reported at the time, an FDA update on February 13 mentioned reports of adverse events linked to Nurse Assist products, which are currently under investigation.
Nurse Assist, a Texas-based manufacturer specializing in water-based medical products used primarily for wound flushing and maintaining medical tubing, initiated the recall in early November. This decision came after routine testing uncovered potential sterility issues with certain saline and water products.
These products were distributed across the United States and Canada from November 2021 to mid-September of the following year. Despite Nurse Assist not receiving any reports of adverse events linked to the affected products, the company recommended the immediate discontinuation of their use and advised customers to contact their distributors for replacements. The recall affected nearly 80 products, with only a dozen marketed under Nurse Assist’s brand, while the rest were distributed by various entities including Cardinal, Covidien, and Medline.
The wide distribution of these products prompted additional recall notices from implicated brands and an updated FDA notice consolidating related recalls. In its February 13 alert, the FDA disclosed reports of adverse events associated with Nurse Assist products, prompting active evaluation of the situation.
Given the Nurse Assists recall situation, Medline also called for the voluntary recall of some of its products containing saline and sterile water including syringes, spray cans, bottles, and cups, this led to approximately 50 notices carrying Class I ratings being added to the recall database the FDA for Medline products.
Cardinal Health also conducted a recall in December, encompassing Cardinal- and Covidien-branded products identified in Nurse Assist’s initial warning. Avanos Medical’s MIC Gastric jejunal feeding tube kits contain sterile water syringes from Nurse Assist and they as a result of the current situation have also announced the voluntary recall of specific lots of their kits. Responding to reports of adverse events, the FDA expanded the recall of additional saline and sterile water products manufactured by Nurse Assist.
In January, several companies proactively recalled their products due to including Nurse Assist water solutions, part of broader efforts to address potential risks associated with Nurse Assist’s water-based medical products. Busse Hospital Disposables took action to recall its care trays and kits, Maquet Cardiovascular withdrew its Atrium Express Dry Suction Dry Seal Chest Drain from circulation and the operative lap P&S surgical kit was recalled by ROi CPS.